Status:
TERMINATED
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surge...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 18 and 65 years inclusive.
- ii) Subjects with current indications for standard metal-on-metal (MoM) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.
- iii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- iv) Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
Exclusion
- i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- ii) Subjects with proven significant osteoporosis and poor bone quality.
- iii) Subjects with compromised renal function.
- iv) Subjects with proven metal sensitivity.
- v) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
- vi) Women who are pregnant.
- vii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- viii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- ix) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
- x) Subjects who are currently involved in any injury litigation claims.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00208377
Start Date
July 1 2003
End Date
December 1 2010
Last Update
June 26 2017
Active Locations (3)
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1
Sportsmed SA
Stepney, Australia
2
Bundesknappshaft Klinik
Püttlingen, Germany
3
Epsom General Hospital
Surrey, United Kingdom